Class 2 Device Recall Sharp Curved Osteotome

• Date Initiated by Firm: December 22, 2017
• Create Date: May 08, 2018
• Recall Status: Terminated on July 16, 2019
• Recall Number: Z-1749-2018
• Recall Event ID: 79518
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: LATARJET EXPERIENCE Sharp Curved Ostetome; ; Product Usage:; The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.
• Code Information: 16D01,16D02, 16K01, 17A01, 17B01, 17B02
• Recalling Firm/ Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.; 325 Paramount Dr; Raynham MA 02767-5199
• For Additional Information Contact: Jennifer Lawrence; 508-880-8100
• Manufacturer Reason for Recall: Reports of product loosening or coming unscrewed from the handle.
• FDA Determined Cause: Process control
• Action: In January of 2018 an URGENT MEDICAL DEVICE RECALL letter was issued to customers requesting all to cease further distribution or use of the product which should be quarantined and returned to the firm. If the product was further distributed it is requested that those customers follow recall procedures. Questions or concerns can be directed to 508-828-3647.
• Quantity in Commerce: 84
• Distribution: US Nationwide Distribution in the states of OH, WA, CO
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.